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  6. eMDR – Electronic Medical Device Reporting
  7. eMDR System Enhancements
  1. eMDR – Electronic Medical Device Reporting

eMDR System Enhancements

This page lists enhancements to CDRH's Electronic Medical Device Reporting (eMDR) system. The FDA eSubmitter client is updated concurrently with the eMDR system, but industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG), should use the information on this page to plan system updates to align with these eMDR system enhancements as soon as possible.

The FDA recognizes the importance of providing early notice and predictability about potential eMDR system changes, especially for manufacturers submitting HL7 ICSR XML reports using AS2. Therefore, the FDA is implementing enhancements to the eMDR System on a regular schedule. 

Through this schedule, the FDA expects to take the next steps for every cycle of new enhancements:  

  1. Announce upcoming enhancements in June,  
  2. Release the Implementation Package in August,  
  3. Deploy enhancements to pre-production (ESG Test) in September, and  
  4. Deploy high-impact enhancements to production 7 months after the Implementation Package is released, typically in March of the following year. 

While the FDA expects to follow this schedule for future enhancements, it is possible that emergency fixes may need to be implemented outside the schedule. Additionally, if major system changes are necessary in the future, additional time will be provided between release of the implementation package and production deployment.

We will provide regular communications on this page at each point in the process. This information will also be emailed to the CDRH Industry's email list.

Please contact the eMDR helpdesk at eMDR@fda.hhs.gov for any questions or concerns about specifications and enhancements. Industry with AS2 accounts may use eMDR Test (through ESG Test) for testing system updates at any time.

Upcoming 2024 Enhancements to eMDR

While some changes will be deployed in November 2024, AS2 submitters have until March 31, 2025 to implement these changes.

Change Comments Schedule
Require Weight Unit if Weight is provided If a number is provided in the weight field, then a weight unit must be selected. Submitters who send an MDR with a weight but without a weight unit selected will receive an Ack 3 rejection message.  

September 2024: Test deployment to eMDR.

March 31, 2025: Production deployment to eMDR

Require all Adverse Event codes in initial MDRs All Adverse Event codes accepted in sections F10 and H6 of the Form 3500A will be required in initial manufacturer and importer reports. All code types have codes that can be used when there is not enough information to select a meaningful code; for more information, see How to Code an MDR Adverse Event Report. Submitters who send an MDR without at least one valid code for each code type will receive an Ack 3 rejection message.  

September 2024: Test deployment to eMDR.

March 31, 2025: Production deployment to eMDR

International Medical Device Regulators Forum (IMDRF) 2024 maintenance updates The Adverse Event codes accepted in sections F10 and H6 of the Form 3500A will be updated to harmonize with maintenance updates from IMDRF. A summary of the changes and the new hierarchy files, will be released in August with the Implementation Package at Coding Resources.

September 2024: Test deployment to eMDR.

November 2024: eSubmitter users can begin using new codes. AS2 users to implement the new codes by March 31, 2025.

Historical Changes to eMDR

Change Comments
2023 eMDR Enhancements 2023 eEnhancements include:
  • No longer accepting multiple G4 PMA, 510(k), or device BLA numbers
  • Update electronic form labels to match Form FDA 3500A 
  • Add the following fields:
    • A3b Patient Gender field
    • D4 Additional Unique Device Identification (UDI) field 
    • Organization Name field under F3 contact information
    • H10 Related Report Numbers field
  • Remove Form Code field
  • Increase H9 FDA Action Code length to 50 characters
  • Accept manufacturer and importer MDRs with 7-digit sequence numbers
  • International Medical Device Regulators Forum (IMDRF) 2023 maintenance updates
2022 eMDR Enhancements 2022 Enhancements include:
  • No longer accepting:
    • Patient Age without patient age unit
    • Blank Product Code
    • Implant date greater than explant date
  • Reports that do not include Adverse Event Problem codes
  • Reports that do not provide a contact email address
  • International Medical Device Regulators Forum (IMDRF) 2022 maintenance updates
2021 eMDR Enhancements 2021 enhancements include:
  • Adverse Event codes accepted in sections F10 and H6 of the 3500A form were updated to harmonize with maintenance updates from IMDRF.
2020 eMDR Enhancements 2020 enhancements include:
  • Exemption Number field added
  • Updates to align with the new FDA Form 3500A 
    • included new options in A3 Patient Gender
    • new fields for C6 Generic and Biosimilar
    • new field for D8 Device Serviced By a Third Party
    • new options for E3 Reporter Occupation
    • new field for G4 PreANDA
    • new field for G5 Combination Product
    • new fields in H1 for Summary Report, for example, Voluntary Malfunction Summary Reports (VMSR) and Number of Events 
    • new fields for H6 Health Effect Impact Code and Medical Device Component Code
  • Adverse Event codes accepted in F10 and H6 were updated to complete harmonization with the IMDRF Adverse Event Reporting Terminologies.
  • IMDRF Adverse Event codes accepted in F10 and H6 were updated to complete harmonization with the IMDRF Adverse Event Reporting Terminologies.
  • Country code formats clarification
    • Two-letter codes are interpreted as FIPS 10-4. 
    • Three-letter codes are interpreted as GENC. 
2018 eMDR Enhancements 2018 enhancements include:
  • Enforcement of Supplement Numbering Requirements
  • FDA Adverse Event codes accepted in F10 and H6 were updated to harmonize with the IMDRF Adverse Event Reporting Terminologies, Annexes A-D
2017 eMDR Enhancements 2017 enhancements include:
  • Environment and Submission Type elements added to Ack3
  • HL7 ICSR R2 XML format update
  • Combination product fields added
  • FDA Form 3500A version 9/30/2018 updates
  • D4 UDI guidance update
  • Reports without B5 and H1 will be rejected

Other Resources

 
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